Human Subjects/IRB

Changes to the Informed Consent

Summary of Changes

  •  [New] "Key information" to be presented at the beginning of the consent form
  • If you are collecting private information or identifiable biospecimens for future research you must include one of the following statements:
    • Identifiers might be removed and the de-identified information or biospecimens used for future research without additional informed consent from the subject.
    • The subject’s information or biospecimens will not be used or distributed for future research studies even if identifiers are removed.
  • Additional Elements of Informed Consent 46.116(c) - Three New Requirements (when appropriate)
  1. Biospecimens: a statement that biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.
  2.  Clinically relevant results: a statement about whether clinically relevant research results, including individual research results, will be disclosed to subjects and if so, under what conditions.
  3.  Whole genome sequencing:  a statement about whether the research project might include whole genome sequencing.

UMass IRB/HRPO has updated the consent templates available on our webpages to reflect these changes.

Studies approved BEFORE January 21, 2019

  • Impact on Researchers: NONE
  • The new consent requirements will NOT be applicable.

Studies approved ON or AFTER January 21, 2019

  • Impact on Researchers: MINIMAL
  • The new consent requirements WILL BE applicable to all studies.
  • UMass IRB/HRPO will provide guidance regarding new requirements for consent documents during the IRB protocol review process.
  • UMass IRB/HRPO has updated the consent templates available on our webpage to reflect these changes (https://www.umass.edu/research/compliance/human-subjects-irb/forms).

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Changes to the Exempt Categories

Summary of Changes

  • [Revised] Exempt Category 2(iii) has now been expanded to allow collection of potentially sensitive or harmful identifiable private information from adults if an IRB conducts a limited review* and determines that there are adequate provisions for protecting privacy and maintaining confidentiality

*The revised Common Rule allows for the exemption of research collecting identifiable information with the potential to cause harm if disclosed, provided that the IRB has determined that “there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data”. This new requirement is called a limited IRB review.

  • [New] Exempt Category 3 "Benign behavioral interventions*" such as solving puzzles or playing online games. Can also collect sensitive information with a limited IRB review

      *Benign behavioral interventions are defined as “brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing”.  Excludes physiological data collection methods (e.g., EEG, wearable devices such as FitBitTM, accelerometers, eye-tracking devices, blood pressure monitors, etc.)

  • [Revised] Exempt Category 4 (medical record review) can now be prospective as well
  • [New] Exempt categories 7 & 8 include limited reviews and Broad Consent.

Studies approved PRIOR to January 21, 2019

  • Impact on Researchers: NONE
  • UMass IRB/HRPO will continue to review all exempt protocols.
    A determination of "exempt" means the proposed research activity meets one of the exemption criteria and thus is exempt from the federal regulations that govern the conduct of human subjects research, Common Rule (45 CFR 46). However, a research activity determined as "Exempt", must still be reviewed by the IRB and conducted in accordance with the ethical principles outlined in the Belmont Report: respect fro persons, beneficence, and justice. Researchers must also comply with all applicable state and local regulations.

Studies approved ON or AFTER January 21, 2019

  • Impact on Researchers: NONE
  • The UMass IRB/HRPO will evaluate each submission and manually assign the applicable Exempt categories per the revised Common Rule. Meanwhile, the researchers should continue to select from the pre-2019 Exempt categories as listed in Kuali.

NOTES:

Please do NOT submit revisions to protocols reviewed under the "Expedited" categories to change the review category to "Exempt".

UMass IRB/HRPO reviews all exempt protocols and thus a review category re-assignment will not make any difference to the IRB protocol review process.

At this time UMass Amherst will not implement new Exempt categories 7 & 8 due to a possible increase in researcher's burden to track and store broad consents. This may change after additional guidance is provided by OHRP.

 

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Changes to the Continuing Review Procedures

Summary of Changes

Continuing review is no longer required for some minimal risk research such as Exempt and Expedited studies that were approved on or after January 21, 2019 unless the IRB explicitly justifies for each study why continuing review would enhance protection of research subjects.

Continuing Review Procedure Changes – Impact on Researchers

FULL BOARD PROTOCOLS

  • Impact on Researchers: NONE
  • Continuing Review/Renewal -STILL REQUIRED (NO CHANGE)
  • Important: Continuing Review requirements for Full Board Protocols remain unchanged.

EXEMPT AND EXPEDITED PROTOCOLS

Studies approved PRIOR to January 21, 2019

  • Impact on Researchers: NONE
  • Continuing Review/Renewal -STILL REQUIRED (NO CHANGE)
  • Studies will continue to require submission of a renewal form annually until the study is completed at which time a final report form must be filed.

Studies approved ON or AFTER January 21, 2019

  • Impact on Researchers: MINIMAL
  • Continuing Review/Renewal - NOT REQUIRED (CHANGED)
  • Continuing review will no longer be required as a general practice unless the IRB reviewer explicitly justifies why continuing review would enhance protection of human research subjects. Your IRB approval letter will indicate the designation as requiring or not requiring a continuing review/renewal.

NOTE: UMASS/HRPO may re-evaluate its decision of not requiring continuing review/renewal for a particular study that was approved ON or AFTER January 21, 2019 based on changes proposed in a revision that increase the risk(s) to subjects, or as an outcome of the IRB's review of unanticipated problems/adverse events/research-related complaints.

UMASS/IRB/HRPO will notify the research if there is any change in the designation.
 

The following research team responsibilities remain unchanged (for both Exempt and Expedited Protocols)

  1. Complete a final report form when all participants have completed all research-related interventions AND you are only doing data analysis of de-identified data.

  2. Submit a revision in the following instances prior to implementation (unless to eliminate an apparent immediate hazard to subjects):

    • Enrollment of additional participants beyond the number approved

    • Any changes to study design/methodology, questionnaires, etc.

    • Any changes to study personnel

    • Any changes to consent procedures/documents

    • Any changes to recruitment procedures/materials

  3. Report the following to the IRB:

    • Unanticipated problems

    • Adverse Events

    • Research-related complaints

    • Protocol deviations/violations

 

 

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New and Revised Definitions

Revised Human Subjects Definition

The definition of “human subject” has been changed to include “identifiable biospecimens” based upon how data and/or biospecimens have been collected or will be used.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. (45 CFR 46.102(e) of the revised Common Rule)

Removal of four categories of activities from the definition of human subject research

The following activities are NOT considered to be human subject research:

  1. Scholarly and journalistic activities that focus directly on the specific individuals about whom the info is collected: (e.g., oral history, journalism, biography, legal criticism, legal research, and historical scholarship)

  2. Public health surveillance activities limited to those conducted, supported, requested, ordered, required, or authorized by a public health authority for public health importance (includes “timely situational awareness”)

  3. Criminal justice or criminal investigational purposes

  4. Authorized activities in support of intelligence, homeland security, defense, or other national security missions.

Addition of the definition of clinical trial

“Clinical trial” means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. (45 CFR 46.102(e) of the revised Common Rule).
 

Impact on Researchers: MINIMAL
UMASS IRB/HRPO has updated the guidance and forms to include the revised definition.

 

 

 

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Certificate of Confidentiality (CoC)

Notice/Policy:  https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-109.html

Summary: Effective October 1, 2017 CoCs will be issued automatically for any NIH-funded project using identifiable, sensitive information that was on-going on/after December 13, 2016

  • The CoC will be issued as a term and condition of award
  • There will be no physical certificate issued

To determine if this Policy applies to research conducted or supported by NIH, investigators will need to ask, and answer the following question:

  • Is the activity biomedical, behavioral, clinical, or other research?

If the answer to this question is no, then the activity is not issued a Certificate. If the answer is yes, then investigators will need to answer the following questions:

  • Does the research involve Human Subjects as defined by 45 CFR Part 46?
  • Are you collecting or using biospecimens that are identifiable to an individual as part of the research?
  • If collecting or using biospecimens as part of the research, is there a small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual?
  • Does the research involve the generation of individual level, human genomic data?

If the answer to any one of these questions is yes, then this Policy will apply to the research

Certificate of Confidentiality Assurance Template (required as a part of the CoC application)

https://humansubjects.nih.gov/coc/assurance-template

Suggested Language regarding CoC for Consent Document: (https://humansubjects.nih.gov/coc/suggested-consent-language )

Suggested consent language:

This research is covered by a Certificate of Confidentiality from the National Institutes of Health. The researchers with this Certificate may not disclose or use information, documents, or biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for this use. Information, documents, or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except, if there is a federal, state, or local law that requires disclosure (such as to report child abuse or communicable diseases but not for federal, state, or local civil, criminal, administrative, legislative, or other proceedings, see below); if you have consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects. 

[Use the following language as applicable] The Certificate cannot be used to refuse a request for information from personnel of the United States federal or state government agency sponsoring the project that is needed for auditing or program evaluation by [THE AGENCY] which is funding this project or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA).  You should understand that a Certificate of Confidentiality does not prevent you from voluntarily releasing information about yourself or your involvement in this research. If you want your research information released to an insurer, medical care provider, or any other person not connected with the research, you must provide consent to allow the researchers to release it.

[language such as the following should be included if researcher intends to disclose  information covered by a Certificate, such as potential child abuse, or intent to hurt self or others in response to specific federal, state, or local laws.] The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, state, or local law of [list what will be reported, such as child abuse and neglect, or harm to self or others]. 

[language such as the following should be included if researcher intends to disclose information covered by a Certificate, with the consent of research participants.] The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you have consented to in this informed consent document [restate what will be disclosed, such as including research data in the medical record].

** Please note that information listed here is subject to change based on additional guidance by NIH. Please continue to monitor this page for additional/updated guidance from NIH.**

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Single IRB (sIRB) Policy for Multi-site Research

Single IRB Policy: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html

Frequently Asked Questions on Use of a Single IRB for Multi-Site Research Costs: https://osp.od.nih.gov/clinical-research/nih-policy-on-the-use-of-a-single-irb-for-multi-site-research-faqs-on-costs/

Frequently Asked Questions on Implementation of the Single IRB Policy: https://osp.od.nih.gov/clinical-research/implementation-of-the-sirb-policy/

For applications with due dates on or after January 25, 2018, and contract solicitations published on or after January 25, 2018, NIH expects that all sites participating in multi-site studies, which involve non-exempt human subjects research funded by the NIH, will use a single Institutional Review Board (sIRB) to conduct the ethical review required for the protection of human subjects.

This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research. It does not apply to career development, research training or fellowship awards. Implementation of the NIH sIRB policy is expected to reduce unnecessary administrative burdens and systemic inefficiencies while maintaining appropriate human subjects protections.

Applicants will be expected to include a plan for the use of a sIRB in the grant applications and contract proposals they submit to the NIH (for due dates on or after January 25, 2018).

The NIH single IRB policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program.

The NIH single IRB policy does not apply to studies conducted under career development, research training or fellowship awards. Under the policy, “multi-site” is defined as two or more sites. Foreign sites participating in NIH- funded, multi-site studies will not be expected to follow this policy.

The NIH single IRB policy applies to multi-site human subjects research regardless of the funding mechanism (e.g., grants, cooperative agreements, contracts or other mechanisms such as Cooperative Research and Development Agreements (CRADAs), and Interagency Agreements (IAA)). The policy applies whether the sites are subawards to a primary award recipient or separate awards are made for participating sites. The NIH Single IRB policy does not apply to Other Transaction Agreements (OTAs).

** Please note that information listed here is subject to change based on additional guidance by NIH. Please continue to monitor this page for additional/updated guidance from NIH.**

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Please remember to download the expanded guidance document linked on the right side of this webpage. The expanded guidance document outlines the following items:

NIH Revisions to the Policies on Definition of a Clinical Trial 

  1. Revised NIH Definition of Clinical Trial
  2. Determination If Your Human Subject’s Research Study Meets the Revised NIH Definition of a Clinical Trial?
  3. Good Clinical Practice (GCP) Training
  4. Data and Safety Monitoring of Clinical Trials
  5. Dissemination of NIH-Funded Clinical Trial Information

** Please note that information listed here is subject to change based on additional guidance by NIH. Please continue to monitor this page for additional/updated guidance from NIH.**

Document File: 

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Ethnographic Research at UMass Amherst

(adapted with gratitude from the University of Connecticut)

Ethnographic Research

Ethnographic research does not always fit neatly into the confines of an IRB application due to its unique characteristics. However, ethnographic research still requires IRB review under the federal regulations, in order to ensure that participants are treated ethically.

The IRB recognizes that ethnographic research has the following special characteristics (Arwood, T., and McGough, H., 2007 PRIM&R SBER Conference):

  • It is experiential
  • It is interactive
  • It is not easily bounded by time and place
  • It is often exploratory
  • It morphs easily and often (new questions emerge during research)
  • The boundaries between normal activities and communication and data collection are blurred

This document is intended as a guide for ethnographic researchers to navigate our Kuai Protocol application form.

Study Procedures

In this section, please provide an overview of how you will go about conducting your ethnography. We recognize that research plans are flexible and may change once you are in the field, but in general, please describe:

  • The kinds of methods, in addition to ethnography, that you will be using in the field (e.g. participant observation, interviews, focus groups, etc.)
  • What will be observed (individual behaviors, community practices, societal norms, etc.) to help the IRB get a sense of what will be analyzed about the participants.
  • How you will decide who to focus on in the community (what criteria you will use to determine the number and demographics of participants, how you will determine when data collection is complete, etc.)
  • Describe where the research will be conducted, and why this setting was chosen. If you have conducted research at this site or with this population previously, briefly describe this.
  • Describe whether local governmental or community permission is required to conduct research at this site – if so, please describe how you will obtain this permission. If there is formal documentation of the permission, please attach it to the attachments section of Kuali.
  • Some countries, and some communities, have their own ethical review requirements, or their own IRBs. Additionally, many countries have the expectation that foreign scholars will collaborate with local scholars and institutions. Explain whether this applies to your research, and if local IRB or other types of ethical review board approval will be obtained.

Subject Population

We recognize that it is not always possible to know ahead of time which or how many people will be involved in the research. In this section, please describe your anticipated participant population to the best of your ability. Specifically:

  • Describe the kinds of people who will be involved in the research – if there are different groups or categories of people, describe the groups and the approximate number of participants anticipated to be enrolled in each group.
  • If the exact number of people to be enrolled are unknown, provide a range.
    • If you find that you are going to exceed this estimate once you’re in the field, please submit a revision to your protocol. These are processed quickly.
  • With regard to “recruitment”, please explain how you’ll introduce yourself as a researcher to potential participants. If you already know the participants, please explain the circumstances. If you’ll be introducing yourself to a group or a community, or if there are culturally specific norms to obtaining consent, please detail this here.

Risks

The American Anthropological Association describes that, “unlike experiments and trials in clinical settings, which have clear beginnings and endings, ethnographic research generally is ongoing, at times sporadic, and takes place in dynamic, natural settings, often where participants are able to decline to participate at any point in the process. Just as in daily life, in these natural settings of research there may be a high probability of risk, but the magnitude of such harm, like uncertainty, mild embarrassment or boredom, is usually low” (http://www.americananthro.org/ParticipateAndAdvocate/Content.aspx?ItemNumber=1652).

The major risks of harm in an ethnographic research project usually involve the risk of invasion of privacy, stigmatization, or breach of confidentiality. When describing risks to participants in an ethnographic setting, please consider the following:

  • Identify the risks of harm that may result from this research. Harm may happen to individuals, or to the groups or communities to which they belong. Examples include:
    • Physical risk – This is usually not a risk in ethnographic research, but could be a risk if you are asking participants to engage in a physical activity, such as a walking tour
    • Psychological risk – Participants may experience stress, discomfort, embarrassment, guilt, etc. when thinking and talking about experiences and opinions about particular topics.
    • Social risk – Participants may encounter stigma or condemnation by their peers. There may be a social risk to the entire community or group.
    • Economic risk – This is not usually a risk in ethnographic research, unless your study takes participants away from profitable activity.
  • Describe the steps you will take to minimize the risks of harm. If harm occurs, what plans to you have to manage it?
  • The potential social risks, particularly in the event of a breach of confidentiality (e.g. disruption of family and personal relationships, embarrassment, uncertainty, discomfort)
  • In politically volatile regions, consider the potential risks to participants of being involved in the research project, and the steps that you will take to protect them.
  • If there are different risks of harm for different groups of participants, please describe the risks for each group. Often this cannot be known in advance of entering the field; if you find once you arrive in the field that the original risks you have indicated are inaccurate, or that new risks have emerged, please inform us as soon as possible by submitting a revision to your protocol.

Benefits

  • If participants will not directly benefit from participation in the research, please state this.
  • Describe any direct benefits that participants will receive from participation in the research. Please note that compensation is not considered a benefit of participation.
  • You may also state the anticipated benefits of the research for the community you will study, for your field, or for society in general.

Attribution and Confidentiality

While the IRB generally strives to protect the confidentiality of research participants’ data, this is not always the goal in ethnographic research. Sometimes participants desire attribution for their words and ideas. When filling out your Kuali application, please address the following:

  • Describe how you will ascertain how the people in this setting feel about the fact that you will write articles about them. Will you consult with the people from whom you collected data before you publish? Will you allow them to read over your work and provide input on whether they feel they are represented accurately?
  • Sometimes, even with pseudonyms, it may be possible to reidentify participants based on contextual factors. If this is the case, due to the location or characteristics of the group you are studying, be sure to disclose this possibility fully in the informed consent.
  • If some of the participants in your research would prefer to have attribution in subsequent publications, explain how you will provide this option to them, and how this may affect those who do not desire attribution with regard to limits of confidentiality.
  • Are any portions of the research material you may collect not publicly available and expected by community standards to be private? If so, please describe which materials are private, and explain:
    • How you will store the private information or materials – both while you are in the field and after you leave the field – so that the confidentiality of the data is protected
    • Whether you will retain information that could lead to identification of the research site and explain any negative consequences this could have
    • If you will record any direct participant identifiers (names, contact information) that could be linked to the private research material.
  • If you will record identifiers, please explain why and describe how you will protect against disclosure of this information, or explain why it is not necessary. If you will retain identifiers linked to data, explain:
    • How long identifiers will be kept
    • How confidentiality will be maintained during this period
    • Who will have access to the data (sponsors, advisors, government agencies, etc.)
    • In each case, explain whether they will have access to study data with identifiers or only to coded data with no access to the identifying study code. If identifiers will be maintained indefinitely, explain why (e.g. you intend to recontact participants or communicate with them over a long period of time, the data is identifiable by nature, etc.)
    • How you will protect the data from a breach of confidentiality
  • If you will retain data that may place participants at risk for criminal or civil liability or be damaging to their financial standing, employability, or reputation, please explain. It may be advisable to obtain a federal Certificate of Confidentiality in this case.

Consent Process in Ethnographies

The three key components of informed consent for any research project are communication of information, comprehension of information, and voluntary participation. Since ethnographies often span years and involve ever-evolving relationships, informed consent often becomes more of a long-term process than a one-time event. As such, please consider and describe the following as you write your protocol:

  • How will you inform people about your research and obtain their consent to participate? If you are introducing yourself to a group, and asking permission to observe them / record field notes, describe how you will allow people in the group to decline to participate.
  • Please let us know of any culturally specific considerations to the consent process (e.g. if it is inappropriate to obtain a signature and it would be better to get “verbal” consent, if it is appropriate in a community to obtain permission from a group of elders before approaching individuals in the group, etc.) and how you will incorporate these considerations into your consent process
  • In the case of a long-term or multi-stage project, consider how you will you work to continually obtain consent from participants – in particular, how you might provide opportunities for people to withdraw from the project entirely, or withdraw particular conversations or interactions from being included as data

Please note that if obtaining a signature on an informed consent document is not appropriate for your participant population (e.g. if participants are not literate, if signing documents is viewed with distrust, etc.), the regulations do provide the option to waive the signature requirement and instead obtain consent verbally. If this is the case for your research, select “alteration” from the informed consent section of Kuali, and answer the questions that follow. If you have questions about the best way to obtain informed consent from your participant population, please feel free to call our office to discuss the particulars of your project.

We understand that the typical informed consent template may not be appropriate for ethnographies, and encourage researchers to craft the consent document to fit the needs of the community (e.g. a letter, an oral script, etc.) The consent process is flexible, but generally must include a communication of the following elements:

  • Statement that the project involves research
  • Explanation of why you are conducting the research
  • Expected duration of participation (if relevant, you can mention that there are different phases to the research project, and that participants will be re-consented during subsequent phases)
  • What participants will be asked to do
  • A description of any risks or potential benefits to participants or others
  • A discussion of confidentiality or attribution
  • Explanation of compensation, if any
  • Explanation that participation is voluntary, and participants may discontinue involvement at any time
  • An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject

If your informed consent document or information sheet needs to be translated into another language, please attach a translated copy to the informed consent section of the protocol once all rounds of comments are complete and the document is finalized.

Assent Process in Ethnographies

If you will be collecting data on children as part of your ethnography, please describe the assent process that you will use to make sure that the children wish to participate. Please also describe how you will obtain parental permission. Please inform us of any cultural considerations with regard to parental permission (e.g. who is the most appropriate person to provide permission for a minor to participate in the research? What is the age of majority in the location where you are conducting research?)

Audio/Photo/Video Use

Some ethnographies involve audio recording participants (during interviews, focus groups, etc.) or taking photo or video images of people.

Our general guidance on audio/visual data collection is available here: https://www.umass.edu/research/guidance/audio-recordings-research-participants

However, there are a few additional considerations when these methods are used as part of an ethnography:

  • Is the consent process for the use of this data continuous? A participant may consent to being audio recorded initially, but later change their mind – is there a mechanism for this?
  • If you are photographing or video recording community events, how will you ensure that only those people who agree to being photographed or video recorded are included in the pictures/footage?
  • If data collection persists over several years, is there a way to check back in with participants to see whether they have changed their mind about the use of their images or video recording?

Ethnographic Interviews

We recognize that ethnographic interviews almost always involve conversation and improvisation. As best you can, please provide us with a rough outline of the kinds of questions that you will be asking of participants. This does not need to be a comprehensive interview schedule, but rather a list of the themes you hope to address, and a representative sampling of the kinds of questions that you will ask. This can be included in the attachments section of Kuali. If you find, once you are in the field, that the focus of your research project has changed and you are asking new questions about different themes, please submit a revision to your protocol.

 

More information: http://www.americananthro.org/ParticipateAndAdvocate/Content.aspx?ItemNumber=1652

http://www.research.uci.edu/compliance/human-research-protections/researchers/ethnographic%20research.html

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Note: If your study/research is funded by NIH please refer to NIH Revision to the Policy on Certificates of Confidentiality.

 

What is a Certificate of Confidentiality?

Certificates of Confidentiality (CoCs) are issued by the National Institute of Health (NIH) to help researchers protect identifiable research information from forced disclosures such as court orders and subpoenas. They allow researchers to refuse to disclose identifying characteristics about research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level.

Eligibility for Certificates of Confidentiality

Certificates of Confidentiality are issued for studies collecting sensitive information which, if disclosed, “could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation.”[i]

In order to be eligible for a Certificate of Confidentiality, the research must collect personally identifiable, sensitive information, and have been approved by the UMass-Amherst IRB. The subject matter of the study must fall within a mission area of the NIH. Some research areas that are eligible for a CoC include:

  • Research on HIV, AIDS, or other STDs;
  • Studies that collect information on sexual attitudes;
  • Studies on the use of alcohol, drugs, or other addictive products;
  • Studies that collect information on illegal conduct;
  • Studies that gather information that if released could be damaging to a participant’s financial standing, employability, or reputation within the community;
  • Research involving information that might lead to social stigmatization or discrimination if it were disclosed;
  • Research on participants’ psychological well-being or mental health;
  • Genetic studies, including those that collect and store biological samples for future use;
  • Research on behavioral interventions and epidemiological studies.

Research does not have to be funded in order to be eligible for a Certificate of Confidentiality.

What a Certificate of Confidentiality Does Not Protect Against

Personally identifiable information protected by a CoC may be disclosed under the following circumstances:

  • Voluntary disclosure of information by study participants themselves or any disclosure that the study participant has consented to in writing, such as to insurers, employers, or other third parties;
  • Voluntary disclosure by the researcher of information on such things as child abuse, reportable communicable diseases, possible threat to self or others, or voluntary disclosures provided that such disclosures are spelled out in the informed consent document;
  • Voluntary compliance by the researcher with reporting requirements of state laws, such as knowledge of communicable diseases, provided such intention to report is specified in the informed consent document; or
  • Release of information by researchers to DHHS as required for program evaluation or audits of research records or to the FDA as required under the federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)

How do I apply for a Certificate of Confidentiality?

The NIH recommends that researchers apply for a Certificate of Confidentiality “at least 3 months prior to the date on which enrollment of research subjects is expected to begin.”[ii] Since applications must have already been approved by the UMass-Amherst IRB before you apply for the CoC, we recommend applying far in advance of the anticipated research date.

You can apply for a Certificate of Confidentiality online at the NIH Certificates of Confidentiality Kiosk website: http://grants.nih.gov/grants/policy/coc/index.htm

Consent Form Language

Researchers must tell their participants about the protections afforded by the Certificate of Confidentiality, and about any exceptions to these protections. For example, if there are any circumstances in which the researchers plan to voluntarily disclose identifying information about research participants (e.g. child abuse, harm to self or others, etc), this must be explicitly included on the informed consent form.

The NIH recommends the following language be added to informed consent documents:

“To help us protect you and the information we will be collecting from you, this study has been given a Certificate of Confidentiality by [identify provider of certificate].  This Certificate means that the researchers cannot be forced, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, to disclose any information that may identify you.  The researchers will use the Certificate to resist any demands of information that would identify you, except as explained below.” 

“The Certificate cannot be used to resist a request for information from United States government employees if the request is for auditing or evaluation of federally funded projects[include the following statement only if FDA regulated research: or for information that must be disclosed to meet the requirements of the federal Food and Drug Administration (FDA).”

“The Certificate does not stop you or a member of our family from voluntarily disclosing to any person information about yourself or your involvement in the study.  If you give your written consent to release study information to an insurer, employer or other person, the Certificate cannot be used to withhold this information.” 

If applicable:
“If any study information is placed into your medical records, the Certificate does not protect that study information.”

If applicable:
“If the researchers become aware of possible child abuse or elder abuse, or that you may cause serious harm to yourself or others, the researchers may report this to the appropriate authorities without your consent.” 

If applicable:
“If the research shows that you have a reportable communicable disease (for example, tuberculosis [TB] or HIV/AIDS), the researchers may report this to state and/or federal public health authorities without your consent.”    

UMass Amherst IRB Review and Certificates of Confidentiality

Please note on your IRB application that you are applying for a Certificate of Confidentiality. Approval of the application will be contingent on receipt of the Certificate of Confidentiality.

UMass-Amherst researchers must submit a copy of their Certificate of Confidentiality to the UMass-Amherst IRB within ten (10) working days of receipt.

UMass Amherst Institutional Official Signature

The NIH requires that both the Principal Investigator and the UMass-Amherst Institutional Official sign the assurances requested in the application for a Certificate of Confidentiality.

In order to obtain a signature from the UMass-Amherst Institutional Official, please forward your completed application to:

  • Assistant Vice Chancellor for Research and Engagement, Compliance and Research Support Services, Jennifer A. Donais

Phone: (413) 545-5896

Address: 101 University Drive Suite C5, Amherst MA 01002

More Information on Certificates of Confidentiality

Additional Research on Certificates of Confidentiality:

Check et. al 2014. “Certificates of confidentiality and informed consent: perspectives of IRB chairs and institutional legal counsel,” IRB Ethics and Human Research 36(1):1-8.

Wolf et. al 2012. “Certificates of Confidentiality: Legal Counsels’ Experiences with and Perspectives on Legal Demands for Research Data,” Journal of Empirical Research on Human Research Ethics 7(4): 1-9.

Wolf et. al 2013. “Certificates of Confidentiality: Protecting Human Subject Research Data in Law and Practice,” Minnesota Journal of Law, Science & Technology 14(1): 11-87.

[i] http://grants.nih.gov/grants/policy/coc/faqs.htm#365

[ii] Ibid.

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